<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20191218045795N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-17</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mirtazapine on neuroleptic-induced acute akathisia</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mirtazapine on neuroleptic-induced acute akathisia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61926</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 4 - block allocationrandom
Patients are placed in two groups A and B by the assistant using the randomized block method. For this randomization, pre-prepared cans and medicines are made by the pharmacist and based on the patients in the order provided by the statistical consultant. The patient and the outcome researcher are unaware of which of the two groups is receiving the medication or placebo.
Random allocation method:
Individuals are assigned to the intervention and control groups using the method of forming 4 random blocks as follows.
AABB, ABAB, BBAA, BABA
A: Intervention Group
B: Control Group
Up to 48 people are randomized using the formation of 4 random blocks and random selection from the sequence of these blocks. For the remaining two people, each of them will be placed in one of the intervention and control groups using the lottery method, Blinding description: placebo was made of inert substances designed to have no effect. In this study, except for the pharmacist who prepared the medication and placebo, all the other people including psychiatrists, patients, and researchers
were blind to the study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>آکاتیزیا.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention in this study is mirtazapine. First, mirtazapine powder (manufactured by Tekaje-Iran under the brand name Rpizapine) which is prepared by a pharmacologist, is poured into empty capsules in the amount of 15 mg with empty scales. Mirtazapine is easily poured from The gastrointestinal tract is absorbed and reaches the maximum blood level within two hours. Extensively metabolized in the liver, the most important biotransformation pathways of this drug are demethylation and oxidation. The capsules are then given to the patients in the intervention group by a trained nurse for 7 days at 9 pm. Intervention 2: Control group: Placebo is prepared based on the color of the requested powder (including flour, starch and pigment) and in the amount of 15 mg in the same capsules where the drug was poured, and it is completely the same shape, color and smell of mirtazapine. It also has no effect on acacia.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
participant individual data

When:
6 months after publication

To whom:
people working in academic institutions

Conditions:
researcher working on academic institution

Where to obtain:
nshamsalizadeh@yahoo.com

How to obtain:
2 month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Shamsalizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Blv.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617978743</zip>
        <telephone>+98 87 3366 4957</telephone>
        <email>nshamsalizadeh@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Shamsalizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Blv.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617978743</zip>
        <telephone>+98 87 3366 4957</telephone>
        <email>nshamsalizadeh@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>currently onantipsychotic medication;
a score of at least 2(mild akathisia) on the global subscale of theBarnes Akathisia Rating Scale (BARS)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>aking betablocker, cyproheptadin ,miancerin, Vitamin B6
suiccidal thoughtsevere
akathisia ,global score  of BARS &gt;5</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G25.71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drug induced akathisia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention in this study is mirtazapine. First, mirtazapine powder (manufactured by Tekaje-Iran under the brand name Rpizapine) which is prepared by a pharmacologist, is poured into empty capsules in the amount of 15 mg with empty scales. Mirtazapine is easily poured from The gastrointestinal tract is absorbed and reaches the maximum blood level within two hours. Extensively metabolized in the liver, the most important biotransformation pathways of this drug are demethylation and oxidation. The capsules are then given to the patients in the intervention group by a trained nurse for 7 days at 9 pm.</i_keyword>
      <i_keyword>Control group: Placebo is prepared based on the color of the requested powder (including flour, starch and pigment) and in the amount of 15 mg in the same capsules where the drug was poured, and it is completely the same shape, color and smell of mirtazapine. It also has no effect on acacia.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>BARS akathisia score. Timepoint: before intervention and 5 day after intervention. Method of measurement: BARS akathisia questionaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-06</approval_date>
        <contact_name>IR.MUK.REC.1397.310</contact_name>
        <contact_address>Pasdaran Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
